Aphthae are inflammatory changes of the oral mucosa which appear in the form of painful tumefactions of oedematous and infiltrative foci covered with a firmly adhering fibrinous film, and ulcera. These tumefactions are roundish and can become as large as lentil beans. Aphthae have multiple etiology and may be caused by infections and allergic reactions, may ensue from internal diseases, or may be of a psychosomatic nature. Also, acid-containing caustic food may lead to inflammations of the oral mucosa.
A mucosa injury may be the result of a self-inflicted bite.
The therapy of such pathological changes of the oral mucosa depends on the severity of the disease and comprises the treatment of possible primary diseases, the avoidance of mouth-care agents, food or stimulants causing pain, and the topical alleviation of pain by anaesthetic-containing pharmaceuticals, such as Anasthesin.TM.-containing pharmaceuticals. Moreover, mild, anti-inflammatory washes or corticoid-containing ointments or lozenges are used.
However, there continues to exist a need for a pharmaceutical which is capable of bringing immediate relief from pain and also of prompting the aphthae to heal quickly without, however, inducing possible systemic side effects.
Dimeticone (dimethylpolysiloxane) is at present used to treat flatulence and meteorism. Moreover, the use of dimethylpolysiloxane in the treatment of ulcerous diseases of the stomach and the duodenum and inflammatory diseases of the esophagus and antrum gastritis is known. For instance, WO 90/07930, which is hereby incorporated herein by reference, describes the capability of dimethylpolysiloxane to form and maintain a protective film in the esophagus, the stomach and the duodenum after oral administration. This results in the healing of the afore-mentioned diseases.